Dataset Information

Self-monitoring and personalized feedback based on the experiencing sampling method as a tool to boost depression treatment: a protocol of a pragmatic randomized controlled trial (ZELF-i).

ABSTRACT:

Background

Depression is a leading cause of disability worldwide. To reduce the societal burden and improve quality of life for individual patients, treatments for depression need to be optimized. There is a particular need for person-tailored interventions that reinforce self-management of patients. Systematic self-monitoring and personalized feedback through the Experience Sampling Method (ESM) could provide such a person-tailored, empowering intervention that enhances treatment outcomes. The primary aim of this study is to investigate the efficacy of self-monitoring and personalized feedback as an add-on tool in the treatment of depressive complaints in a natural setting.

Methods

The ZELF-i study is a pragmatic multi-site randomized controlled trial (RCT). We aim to recruit 150 individuals with depressive symptoms aged between 18 and 65 years, who have an intake for outpatient basic or specialized treatment at a mental health care organization in the North of the Netherlands. After the intake, participants will be randomly allocated to one of three study arms: two experimental groups engaging in 28 days of systematic self-monitoring (5 times per day) and receiving weekly personalized feedback on positive affect and activities ("Do"-module) or on negative affect and thinking patterns ("Think"-module), and a control group receiving no additional intervention. Self-report inventories of depressive symptoms, psychosocial functioning and feelings of empowerment will be administered before and after the intervention period, and at follow-up measurements at 1, 2, 3 and 6 months. The patient-experienced utility of the intervention will be investigated by a combination of quantitative and qualitative research methods.

Discussion

The present study is the first to examine the effects of add-on self-monitoring and personalized feedback on depressive complaints in clinical practice. It is also the first to evaluate two different ESM modules targeted at both of depression's core symptoms. Lastly, it is the first study that uses a combination of qualitative and quantitative methods to evaluate the patient-experienced utility of ESM with personalized feedback as an intervention for depression. Results of the present study may improve treatment for depression, if the intervention is found to be effective.

Trial registration

Dutch Trial Register, NTR5707 , registered prospectively 1 February 2016.

SUBMITTER: Bastiaansen JA

PROVIDER: S-EPMC6122175 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Publications

Self-monitoring and personalized feedback based on the experiencing sampling method as a tool to boost depression treatment: a protocol of a pragmatic randomized controlled trial (ZELF-i).

Bastiaansen Jojanneke A JA Meurs Maaike M Stelwagen Renee R Wunderink Lex L Schoevers Robert A RA Wichers Marieke M Oldehinkel Albertine J AJ

BMC psychiatry 20180903 1

<h4>Background</h4>Depression is a leading cause of disability worldwide. To reduce the societal burden and improve quality of life for individual patients, treatments for depression need to be optimized. There is a particular need for person-tailored interventions that reinforce self-management of patients. Systematic self-monitoring and personalized feedback through the Experience Sampling Method (ESM) could provide such a person-tailored, empowering intervention that enhances treatment outcom ...[more]

PMID: 30176845

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Project description:BackgroundMajor depressive disorder (MDD) is a highly prevalent mental disorder with large disease burden, high levels of relapse or persistence, and overall suboptimal outcomes of protocolized pharmacological and psychotherapeutic treatments. There is an urgent need to improve treatment effectiveness, possibly through systematic treatment personalization. In psychotherapeutic treatments this can be achieved by case conceptualization. To support this process, we developed the Therap-i module, which consists of personalized Experienced Sampling Methodology (ESM) and feedback. The Therap-i module is integrated into outpatient psychotherapeutic treatment as usual (TAU) for depression. The study aim is to investigate the efficacy of the Therap-i module in decreasing symptomatology in unresponsive or relapsing patients diagnosed with MDD. We hypothesize that the Therap-i module will contribute to TAU by i) decreasing depressive symptoms, and ii) improving general functioning, therapeutic working alliance, and illness perception. This paper provides details of the study rationale, aims, procedures, and a discussion on potential pitfalls and promises of the module.MethodsPatients diagnosed with MDD (n = 100) will enrol in a pragmatic two-armed randomized controlled trial. Randomization is stratified according to the patient's treatment resistance level assessed with the Dutch Method for quantification of Treatment Resistance in Depression (DM-TRD). All fill-out the Inventory of Depressive Symptomatology Self Report (IDS-SR), Outcome Questionnaire (OQ-45), Illness Perception Questionnaire Mental Health (IPQ-MH), and Work Alliance Inventory Self Report (WAI-SR). In the intervention arm, through close collaboration between patient, clinician, and researcher, a personalized ESM diary is developed based on the patient's case conceptualization. During the ESM monitoring period (8 weeks, 5 assessments/day), patients receive feedback three times, which is discussed among the abovementioned three parties. Both patients and clinicians will evaluate the Therap-i module.ResultsData collection is ongoing.DiscussionThis is the first study in which personalized ESM and feedback is integrated in outpatient psychotherapeutic TAU for depression. The labour intensive procedure and methodological pitfalls are anticipated challenges and were taken into account when designing the study. When hypotheses are confirmed, the Therap-i module may advance treatment for depression by providing insights into personalized patterns driving or perpetuating depressive complaints.Trial registrationTrial NL7190 (NTR7381) , registered prospectively 03-08-2018.

Project description:BackgroundPatients with obsessive-compulsive disorder (OCD) suffer from repetitive fearful intrusions which they try to neutralize by performing compulsions. OCD is considered to be the most resistant anxiety disorder with a remission rate of only 53% after a year of an evidence-based treatment. Therefore, it remains an obligation to develop and investigate more effective treatment interventions. This study aims to compare personalized exposure with response prevention (ERP) using experience sampling methodology-based feedback to ERP as usual in patients with OCD. Personalized exposure will be provided screen-to-screen in an ecologically valid (real time and real place) context by means of a smartphone application. This app will also be used to collect both objective and subjective data by means of experience sampling methodology (ESM). This ESM data will be used to identify triggers and protective factors for symptom severity, provide personalized feedback and optimize the effect of ERP. The primary goal of this RCT is to compare the effectiveness of personalized ERP to ERP as usual in the traditional context of a therapist's room in patients with OCD in OCD symptom severity, as well as differences in quality of life, depressive symptoms and anxiety states. Since both self-efficacy and experiential avoidance are known to influence symptom severity in OCS, a secondary goal is to examine if a possible treatment effect is mediated by self-efficacy or experiential avoidance.MethodsThis study involves a randomized controlled trial with 20 weekly sessions by 2 groups (ERP as usual versus personalized ERP), repeated measurements at baseline (T0), 5 weeks of treatment (T1), 10 weeks of treatment (T2), 15 weeks of treatment (T3), posttest at 20 weeks (T4), 6 weeks follow-up (T5), 3 months follow-up (T6), 6 months follow-up (T7) and a year follow-up (T8). A hundred and sixty patients with an OCD diagnosis according to DSM-5 criteria will participate. Half of the group will receive exposure with response prevention as usual, the other half will receive personalized exposure with response prevention with a smartphone application and personalized feedback sessions based on experience sampling data. Multilevel mixed modelling analysis will be used to investigate differences in treatment effect, as well as differences in quality of life, depressive symptoms and anxiety states. We will use the macro of Preacher and Hayes and apply bootstrapping methods to assess the possible mediating effect of changes in self-efficacy and experiential avoidance on subsequent treatment effects.DiscussionThis randomized controlled trial is the first to assess the influence of delivering ERP through video-calling and the use of an ESM intervention on the symptom severity of OCD. Since the global pandemic COVID-19, the use of video-calling to deliver psychological treatments has become more common, increasing the relevance of this study.Trial registrationICTRP Trial NL8254. Registered on 2019-12-24.

Project description:ObjectivesPositive affect (PA) plays a crucial role in the development, course, and recovery of depression. Recently, we showed that a therapeutic application of the experience sampling method (ESM), consisting of feedback focusing on PA in daily life, was associated with a decrease in depressive symptoms. The present study investigated whether the experience of PA increased during the course of this intervention.DesignMulticentre parallel randomized controlled trial. An electronic random sequence generator was used to allocate treatments.SettingsUniversity, two local mental health care institutions, one local hospital.Participants102 pharmacologically treated outpatients with a DSM-IV diagnosis of major depressive disorder, randomized over three treatment arms.InterventionSix weeks of ESM self-monitoring combined with weekly PA-focused feedback sessions (experimental group); six weeks of ESM self-monitoring combined with six weekly sessions without feedback (pseudo-experimental group); or treatment as usual (control group).Main outcomeThe interaction between treatment allocation and time in predicting positive and negative affect (NA) was investigated in multilevel regression models.Results102 patients were randomized (mean age 48.0, SD 10.2) of which 81 finished the entire study protocol. All 102 patients were included in the analyses. The experimental group did not show a significant larger increase in momentary PA during or shortly after the intervention compared to the pseudo-experimental or control groups (χ2(2) = 0.33, p = .846). The pseudo-experimental group showed a larger decrease in NA compared to the control group (χ2(1) = 6.29, p =.012).ConclusionPA-focused feedback did not significantly impact daily life PA during or shortly after the intervention. As the previously reported reduction in depressive symptoms associated with the feedback unveiled itself only after weeks, it is conceivable that the effects on daily life PA also evolve slowly and therefore were not captured by the experience sampling procedure immediately after treatment.Trial registrationTrialregister.nl/trialreg/index.asp. NTR1974.

Dataset Information

Self-monitoring and personalized feedback based on the experiencing sampling method as a tool to boost depression treatment: a protocol of a pragmatic randomized controlled trial (ZELF-i).

Background

Methods

Discussion

Trial registration

Publications

Self-monitoring and personalized feedback based on the experiencing sampling method as a tool to boost depression treatment: a protocol of a pragmatic randomized controlled trial (ZELF-i).

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